DWP · Class II · 21 CFR 870.4475

FDA Product Code DWP: Dilator, Vessel, Surgical

Leading manufacturers include American Edwards Laboratories, Shiley, Inc. and Bio-Vascular, Inc..

20
Total
20
Cleared
116d
Avg days
1979
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Dilator, Vessel, Surgical Devices (Product Code DWP)

20 devices
1–20 of 20
Cleared Apr 20, 2023
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
K220981
Fehling Surgical Instruments, Inc.
Cardiovascular · 381d
Cleared Sep 03, 2019
Geomed Vascular Dilators
K183438
Geomed Medizin-Technik GmbH & Co.
Cardiovascular · 265d
Cleared Jun 29, 2017
Vessel Dilator
K163524
Fetzer Medical GmbH & Co. KG
Cardiovascular · 196d
Cleared Apr 24, 2013
VASCULAR PROBE, VASCULAR PROBE ES
K130896
Synovis Life Technologies, Inc.
Cardiovascular · 23d
Cleared Apr 19, 1996
RDI CARDIAC INSULATION PAD
K960312
R D Intl.
Cardiovascular · 88d
Cleared Jul 02, 1991
LAPAROSCOPIC VESSEL ARTICULATOR
K911475
United States Endoscopy Group, Inc.
Cardiovascular · 89d
Cleared May 08, 1991
ROBICSEK PROBE/RETRACTOR
K910682
Bio-Vascular, Inc.
Cardiovascular · 78d
Cleared Feb 07, 1991
FLO-RESTER(R) VESSEL SIZER
K905159
Bio-Vascular, Inc.
Cardiovascular · 83d
Cleared Oct 16, 1990
FOGARTY VESSEL CALIBRATOR
K902143
Baxter Healthcare Corp
Cardiovascular · 154d
Cleared Oct 12, 1989
PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)
K891786
Pioneering Technologies, Inc.
Cardiovascular · 202d
Cleared Aug 31, 1983
VESSEL DILATOR
K832595
Abbott Laboratories
Cardiovascular · 29d
Cleared Oct 04, 1982
REUSABLE FOGARTY FLEXIBLE CALIBRATOR
K822687
American Edwards Laboratories
Cardiovascular · 31d
Cleared Nov 16, 1981
FOGARTY FLEXIBLE PROBE
K812935
American Edwards Laboratories
Cardiovascular · 27d
Cleared May 15, 1981
FOGARTY FLEXIBLE CALIBRATOR
K810894
American Edwards Laboratories
Cardiovascular · 42d
Cleared Dec 04, 1979
BONCHEK-SHILEY VEIN DISTENTION SYSTEM
K792134
Shiley, Inc.
Cardiovascular · 43d
Cleared Jun 13, 1979
SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO
K790938
Shiley, Inc.
Cardiovascular · 26d

About Product Code DWP - Regulatory Context

510(k) Submission Activity

20 total 510(k) submissions under product code DWP since 1979, with 20 receiving FDA clearance (average review time: 116 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.